Analysis of Cannabidiol (CBD) and THC in Nonprescription Consumer Products: Implications for Patients and Practitioners

Abstract appeared in PubMed

Purpose: Cannabidiol products remains largely unregulated in the US. Unlike the Rx formulation of CBD [EpidiolexR], little information is available regarding labeling accuracy (does the product contain what the label says it does), lot to lot variability, nor long-term product stability.

Understanding these properties are fundamental if these products are to be used in patients with epilepsy, where product variability of traditional AEDs has been suspected to result in inadequate seizure control.

Therefore, we analyzed commercial CBD products, including oils, aqueous products (i.e., beverages), and various Other products for cannabinoid content vs label claims and stability under United States Pharmacopeia (USP) standards.

Method: Samples were diluted and analyzed by HPLC for CBD, THC, and CBN concentrations in order to assess product label accuracy. Products with <90% of label claim CBD were denoted over-labeled, products with >110% of label claim CBD were denoted under-labeled, and products between 90% and 110% of label claim CBD were denoted appropriately labeled, per USP standards.

Results: Among commercial CBD Oils (n?=?11), mean CBD concentration vs label claim was 91.56% [95% CI, 66.02–117.10%], although 18.18% of oils (n?=?2) made nonspecific label claims of “hemp extract” in lieu of CBD. Among all oils, 36.36% (n?=?4) were appropriately labeled, another 36.4% (n?=?4) of all oils were under-labeled, maximum 128.3% label claim, and finally, 9.09% (n?=?1) of oils were over-labeled. The remaining 18.18% (n?=?2) of oils lacked specific CBD label claims, minimum of 0.3?mg CBD per 1-ml “dose”. THC was detected in 54.55% (n?=?6) of oils with a maximum concentration of 0.2% w/v and a minimum concentration of 0.036% w/v. Cannabinol was detectable in only 9.1% (n?=?1) of products at a concentration of 0.00465% w/v.

Among aqueous products (n?=?21) tested, only 66.67% (n?=?14) gave specific CBD label claims, with mean CBD concentration vs label claim of 59.93% [95% CI, 38.24–81.63%]. Only 7.14% (n?=?1) of aqueous products with a label claim were appropriately labeled, 14.29% (n?=?2) were found to be under-labeled, and 78.57% (n?=?11) over-labeled. THC was detected in 23.81% (n?=?5) of aqueous products tested with a maximum THC concentration of 0.0005% w/v, and a minimum concentration of 0.0002% w/v. Cannabinol was detected in 9.52% (n?=?2) of aqueous products, both at a concentration of 0.0015% w/v.

“Other” products (n?=?7) tested ranged from chocolate bars to transdermal patches. Some 42.86% (n?=?3) gave specific CBD label claims, with mean CBD concentration vs label claim of 67.01% [95% CI, 0.87–133.14%]. Among these three “Other” products with specific label claims, 33% (n?=?1) was appropriately labeled, and 66.67% (n?=?2) were over-labeled, with CBD concentrations vs label claim ranging from a minimum of 39.30% to a maximum of 101.99%.

The remaining 57.14% (n?=?5) of “Other” products tested made nonspecific CBD label claims, denoting CBD content in terms of “full spectrum hemp extract” or “activated cannabinoids”. One such product was labeled with a “40–50-mg CBD” range instead of a single, specific value. Tetrahydrocannabinol was detected in 71.43% (n?=?5) of Other products tested with a maximum concentration of 0.0046% w/w, and a minimum concentration of 0.0008% w/w. Cannabinol was detected in 14.3% (n?=?1) of Other products at a concentration of 0.0001% w/w.

Conclusion: We demonstrate that commercial CBD products, especially aqueous beverages, can show inconsistent labeling, vary largely from their label claims should they make them, and show lot-to-lot variability making dosing unpredictable.

What is the Community’s Knowledge and Understanding Regarding Epilepsy? Epilepsy Knowledge and its Determinants Among Residents of Debub Bench District, Bench Sheko Zone, Southwest Ethiopia, 2019: a Cross-Sectional Study

Abstract appeared in DocWire News

OBJECTIVE: Epilepsy is a neurological condition marked by recurring seizures. People with epilepsy, particularly in low-income and middle-income countries, are stigmatised due to a lack of understanding and a negative attitude towards the disease. Increased public awareness of epilepsy will aid in the search for therapy and the quality of life of the patients. The study aimed to assess knowledge about epilepsy and the associated factors among residents of Debub Bench District, Bench Sheko Zone, Southwest Ethiopia in 2020.

SETTING: This community-based, cross-sectional study triangulated with qualitative method was conducted from 25 April 2020 to 20 May 2020. Multistage sampling technique was used to select 601 participants. A structured and interviewer-administered questionnaire was used to collect data. Data were entered in EpiData Manager V. and exported to SPSS V.23 for analyses. Multivariable logistic regression was carried out to identify the factors associated with knowledge of epilepsy. A p value of <0.05 was taken to indicate statistical significance.

RESULTS: A total of 601 respondents participated, of whom 340 (56.6%) were male. The mean age of the respondents was 34.84±11.42 years. The proportion with good knowledge of epilepsy was 55.1%. Factors associated with good knowledge of epilepsy were attending primary education (adjusted OR (AOR)=2.06, 95% CI 1.27 to 3.34), secondary education (AOR=5.01, 95% CI 2.62 to 9.58), above secondary education (AOR=5.67, 95% CI 2.35 to 13.69), being in high wealth index (AOR=1.74, 95% CI 1.09 to 2.78), being a government employee (AOR=3.69, 95% CI 1.39 to 9.83), being a merchant (AOR=3.16, 95% CI 1.80 to 5.54) and being an urban resident (AOR=2.15, 95% CI 1.36 to 3.42).

CONCLUSION: Only 55% of the residents have sufficient knowledge about epilepsy. Factors associated with knowledge of epilepsy were educational status, wealth index, occupation and residence.

The Initial Impact of the SARS-CoV-2 Pandemic on Epilepsy Research

Abstract appeared in Wiley Online Library

The COVID-19 pandemic has changed the face of many practices throughout the world. Through necessity to minimize spread and provide clinical care to those with severe disease, focus has been on limiting face-to-face contact. Research in many areas has been put on hold. We sought to determine the impact of the COVID-19 pandemic on epilepsy research from international basic science and clinical researchers. Responses to five questions were solicited through a convenience sample by direct email and through postings on the ILAE social media accounts and an ILAE online platform (utilizing Slack). Information was collected from 15 respondents in 11 countries by email or via Zoom interviews between May 19, 2020, and June 4, 2020. Several themes emerged including a move to virtual working, project delays with laboratory work halted and clinical work reduced, funding concerns, a worry about false data with regard to COVID research and concern about research time lost. However, a number of positive outcomes were highlighted, not least the efficiency of online working and other adaptations that could be sustained in the future.

Substantial Early Changes in Bone and Calcium Metabolism Among Adult Pharmacoresistant Epilepsy Patients on a Modified Atkins Diet

Abstract appeared in Wiley Online Library

Objective: The aim of this study was to investigate whether the modified Atkins diet (MAD), a variant of the ketogenic diet, has an impact on bone- and calcium (Ca) metabolism.

Methods: Two groups of adult patients with pharmacoresistant epilepsy were investigated. One, the diet group (n = 53), was treated with MAD for 12 weeks, whereas the other, the reference group (n = 28), stayed on their habitual diet in the same period. All measurements were performed before and after the 12 weeks in both groups. We assessed bone health by measuring parathyroid hormone (PTH), Ca, 25-OH vitamin D (25-OH vit D), 1,25-OH vitamin D (1,25-OH vit D), phosphate, alkaline phosphatase (ALP), and the bone turnover markers procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide collagen type 1 (CTX-1). In addition, we examined the changes of sex hormones (estradiol, testosterone, luteinizing hormone, follicle-stimulating hormone), sex hormone-binding globulin, and leptin.

Results: After 12 weeks of MAD, we found a significant reduction in PTH, Ca, CTX-1, P1NP, 1,25-OH vit D, and leptin. There was a significant increase in 25-OH vit D. These changes were most pronounced among patients <37 years old, and in those patients with the highest body mass index (?25.8 kg/m²), whereas sex and type of antiseizure medication had no impact on the results. For the reference group, the changes were nonsignificant for all the analyses. In addition, the changes in sex hormones were nonsignificant.

Significance: Twelve weeks of modified Atkins diet (MAD) treatment leads to significant changes in bone and Ca metabolism, with a possible negative effect on bone health as a result. A reduced level of leptin may be a triggering mechanism. The changes could be important for patients on MAD, and especially relevant for those patients who receive treatment with MAD at an early age before peak bone mass is reached.

The Effect of Epilepsy Surgery on Productivity

Abstract appeared in Wiley Online Library

 Objectives: An important but understudied benefit of resective epilepsy surgery is improvement in productivity; that is, people’s ability to contribute to society through participation in the workforce and in unpaid roles such as carer duties. Here, we aimed to evaluate productivity in adults with drug-resistant epilepsy (DRE) pre- and post-resective epilepsy surgery, and to explore the factors that positively influence productivity outcomes.

Methods: We conducted a systematic review and meta-analysis using four electronic databases: Medline (Ovid), EMBASE (Ovid), EBM Reviews – Cochrane Central Register of Controlled Trials (CENTRAL), and Cochrane Library. All studies over the past 30 years reporting on pre- and post-resective epilepsy surgical outcomes in adults with DRE were eligible for inclusion. Meta-analysis was performed to assess the post-surgery change in employment outcomes.

Results: A total of 1005 titles and abstracts were reviewed. Seventeen studies, comprising 2056 unique patients, were suitable for the final quantitative synthesis and meta-analysis. Resective epilepsy surgery resulted in a 22% improvement in overall productivity (95% confidence interval [CI]: 1.07–1.40). The factors associated with increased post-surgery employment risk ratios were lower pre-surgical employment in the workforce (relative risk ratio [RRR] =0.34; 95% CI: 0.15–0.74), shorter follow-up duration (RRR = 0.95; 95% CI: 0.90–0.99), and lower mean age at time of surgery (RRR= 0.97; 95% CI: 0.94–0.99). The risk of bias of the included studies was assessed using Risk Of Bias In Non-randomised Studies – of Interventions and was low for most variables except ”measurement of exposure.”

Significance: There is clear evidence that resective surgery in eligible surgical drug-resistant epilepsy (DRE) patients results in improved productivity. Future work may include implementing a standardized method for collecting and reporting productivity in epilepsy cohorts and focusing on ways to reprioritize health care resource allocation to allow suitable candidates to access surgery earlier. This will ultimately benefit individuals with DRE, their families, our communities, and the wider health care system.

Effectiveness of Zonisamide (Zonegran®) in Childhood Refractory Epilepsy

Abstract appeared in PubMed

Introduction: Zonisamide (ZNS) is a new generation antiepileptic drug (AED) used in refractory epilepsy. This study assessed the effectiveness and reliability of ZNS in childhood refractory epilepsy.

Method: Sixty-eight epilepsy patients who were followed up in the paediatric neurology clinic, between 2013 and 2019, and in whom add-on therapy ZNS had been added as their seizures had continued despite multiple drugs being used, were included in this retrospective study. Their demographic findings, seizure aetiology, pre-treatment and post-treatment electroencephalography findings, treatment responses and any side effects of the drugs given were assessed in these patients.

Results: There were 46 (67.6%) patients in the refractory generalized epilepsy (RGE) group using multiple AEDs and 22 (32.35%) patients in the refractory focal epilepsy (RFE) group. Of these patients, 12 (17.65%) were being followed up for idiopathic epilepsy and 8 (11.76%) were being followed up for epilepsy of unknown aetiology. Twenty-two (32.36%) patients were followed up for structural abnormality, 8 patients (11.77%) were followed up for genetic disease, 4 patients (5.88%) were followed up for infectious sequel, 14 patients (20.59%) were followed up for metabolic reasons. In the RGE group, a more than 50% reduction was found in the seizures of 26 (56.5%) patients, while the seizures of 7 (15.2%) patients were found to have terminated completely. In the RFE group, a more than 50% reduction was found in the seizures of 19 (86.4%) patients, while the seizures of 2 (9.1%) patients were found to have terminated completely. The termination or a more than 50% reduction in seizures in 4 of the 6 patients followed up for a diagnosis of tuberous sclerosis complex (TSC) was significant.

Conclusion: ZNS is an effective and reliable option as an add-on therapy in paediatric refractory epilepsy, especially in focal epilepsy. It can also be considered for treatment in TSC patients.

The Beneficial Effect of Probiotics Supplementation on Penicillin-Induced Focal Seizure in Rats

Abstract published in PubMed

The focal epilepsy is a chronic neurological brain disorder which affects millions of people in the world. There is emerging evidence that changes in the gut microbiota may have effects on epileptic seizures. In the present study, we examined the effect of probiotics on penicillin-induced focal seizure model in rats. Male Wistar Albino rats (n: 21) were randomly divided into three groups: control (no medication), penicillin and penicillin + probiotic. Probiotic VSL#3 (12.86 bn living bacteria/kg/day) was given by gavage for 30 days. The seizures were induced by intracortical injection of penicillin G (500 IU) into the cortex. An ECoG recordings were made for 180 min after penicillin G application. The spike frequency and the amplitude were used to assess the severity of seizures. Tumor necrosis factor (TNF-?), nitric oxide (NO) and interleukin (IL-6) levels in the brain were studied biochemically. Our results indicated that probiotic supplementation improved focal seizures through increasing the latency (p < 0.001) and decreasing the spike frequency (p < 0.01) compared to the penicillin group. Penicillin-induced seizure in rats significantly enhanced TNF-? (p < 0.01), NO (p < 0.01) and IL-6 (p < 0.05) compared to the control. Probiotic supplementation significantly decreased IL-6 (p < 0.05), TNF-? (p < 0.01) and NO (p < 0.001) compared to the penicillin group. When the body weights were compared before and after the experiment, there was no difference between the control and penicillin groups, but it was observed that the body weight decreased after probiotic supplementation in the penicillin + probiotic group.

Probiotic supplementation may have anti-seizure effect by reducing proinflammatory cytokine and nitric oxide levels in epileptic rat brain.

Clinical Trial: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR)

The VALOR study is investigating whether Lacosamide (Vimpat®)—when taken with current anti-epileptic medicine—helps decrease the number of seizures patients experience. This study enrolls children and adults who are at least 4 years or older, have epilepsy with primary generalized tonic-clonic seizures, had at least 2 seizures in the past 12 weeks, and are on a stable dose of anti-epileptic medicines. Patients have a 50% chance of receiving placebo; they have the opportunity to receive Lacosamide for another two years afterwards in an open-label extension study. The study is running in a total of 23 countries, including the United States.

Eligibility Criteria:

Ages Eligible for Study: 4 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalizedtonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
  • Subject has 3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
  • If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
  • Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Antiepileptic drugs (AEDs) OR 1 to 3 AEDs (with 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS)
  • Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer


Exclusion Criteria:

  • History of partial onset seizures or EEG findings indicating partial onset seizures
  • Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
  • Lifetime history of suicide attempt, or suicidal ideation in past 6 months
  • Women of child bearing potential must practice contraception according to protocol requirements
  • Regular use of clozapine, monoamine oxidase (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
  • Use of Vigabatrin within the last 6 months

Mayor Emanuel Interviews Singer, Actor and “Hamilton” Star Miguel Cervantes on “Chicago Stories”

On this week’s episode of “Chicago Stories” the star of Chicago’s “Hamilton” Miguel Cervantes gives Mayor Emanuel his take on the smash-hit musical, shares the story of his hard-won career, and talks about his biggest role of all as “Dad” and raising awareness for childhood epilepsy.

Born and raised in Dallas, Miguel wasn’t interested in theater growing up, at least not at first, but an audition for a local production in sixth grade planted the first step to a journey that took him to Dallas’ Booker T. Washington High School for the Performing Arts, Boston’s Emerson College, and then finally the bright lights of Broadway?—?or so he thought.

“When I graduated I went right to New York as the big fish in my school,” Miguel said. “I thought: ‘this is great, this is easy, this is going to be awesome,’ and then crash and burn.”

As Miguel told Mayor Emanuel, he wasn’t ready. (Though, as Mayor Emanuel told Miguel, the real problem was New York wasn’t ready for him.)

After a brief return home, Miguel hooked up with friends in Boston and embarked on an artistic rebirth that eventually brought him back to the Big Apple, but this time to a mix of Broadway, Off-Broadway, and touring productions.

“Opportunity comes at its own pace,” Miguel said, “and sometimes your opportunity is not when you’re 21 when you think you’re ready?—?that may not be the right time for you.”

For Miguel, opportunity came in a big way in 2016 when the mega-hit “Hamilton” was looking to recast its famous title role. Immediately once auditions started, Miguel could tell something was different.

“Three weeks later, after four auditions, I called my wife and said ‘I think we’re moving to Chicago,’” Miguel said.

Miguel’s biggest role of all though has been as “Dad” to his six-year-old son and two-year-old daughter Adelaide, who at seven-months-old was diagnosed with epilepsy just as “Hamilton” was coming into his life.

As devastating as childhood epilepsy is, the news got worse after doctors discovered Adelaide had “infantile spasms,” a particularly devastating form of epilepsy that can lead to severe developmental and cognitive delays.

Not knowing where to go or who to turn to, Miguel and his wife Kelly connected with the Chicago-based Citizens United in Research for Epilepsy, or “CURE,” the nation’s largest non-governmental organization funding epilepsy research.

“We got here terrified, just absolutely terrified,” Miguel told Mayor Emanuel. “And we come to Chicago and the folks at CURE wrapped their arms around us and said ‘we got you here.’”

Since then both Miguel and Kelly have become passionate advocates for epilepsy awareness through CURE, including their My Shot at Epilepsy fundraising campaign and the #MyShotAtEpilepsy Challenge.

Today, 3.4 million Americans suffer from epilepsy, including 470,000 children, while an estimated 65 million people currently life with epilepsy worldwide. Meanwhile, research is still underfunded, and comprehensive treatment for families like the Cervantes’ is still a long way off.

“What we say is we may not be able to do so much for [Adelaide]—what we can actually achieve in her life may be limited,” Miguel said, “but if we raise our voices and do everything that we can, at some point some parents will not have to go through what we have to go through.”

Be sure to listen to the full episode as Miguel and Mayor Emanuel talk about the impact of “Hamilton,” Chicago’s theater community and culture of giving back, and where Miguel hopes opportunity takes him next.

You can check out the full episode on iTunesSoundCloud, and Spotify.

April 2018 CURE Update

I took a brief break from overseeing CURE’s research efforts last week to attend a CURE Benefit in Boston hosted by Anne Finucane & Mike Barnicle as well as Susan & David Axelrod. I’m so grateful to them for being such wonderful hosts and would like to thank all those who attended.

At the event, CURE’s founder Susan Axelrod spoke about the importance of epilepsy research and highlighted our plans to work with the Department of Defense on Post-Traumatic Epilepsy. I had the opportunity to speak about recent CURE-funded research that may lead to important diagnostic and treatment advances.

The 2018 Boston Benefit for the Cure was a wonderful opportunity to get together with members of our passionate community who are dedicated to finding a cure.

Couldn’t attend the Boston event? Read on… you can participate in other ways. Our next online webinar will feature news about promising anti-epileptic drugs in development. Or, if you’re looking to attend an event in-person, I’ve included information about CURE’s next Day of Science events as well as additional news and events that I’m excited to share with you.

Best regards,
Dr. Laura Lubbers

Promising Anti-Epileptic Drugs in Development ? Webinar

This free webinar will outline therapies in development for epilepsy and seizures, including promising therapies for patients with treatment-resistant epilepsy and children with severe epilepsy. The webinar will also focus on drugs that may not only reduce seizures, but improve treatment of the underlying disease.

Register Now

The webinar will be presented by Dr. Jacqueline French, a professor of Neurology in the Comprehensive Epilepsy Center at NYU Langone School of Medicine and Founder/Director of the Epilepsy Study Consortium. Dr. French’s presentation will be followed by an interactive Q&A session.

The information session is scheduled for Wednesday, April 18, 2018 at 1pm EDT / 2pm CDT. The webinar is free, but you do need to register.

View Past Webinars

2018 Epilepsy Scholarships: Application Deadline April 15

The deadline for CURE’s 2018 Educational Enrichment Fund (EEF) Scholarship is right around the corner! Applications are due to CURE by April 15, 2018 at 11:59pm CDT.

Made possible by the generous funding of Lundbeck, CURE’s EEF Scholarship program provides a one-time scholarship (up to $5,000) to be used toward coursework that will advance personal knowledge in the field of epilepsy as it relates to research, health education, awareness, and/or advocacy. Anyone diagnosed with epilepsy, immediate family members, and/or caregivers of someone with epilepsy are encouraged to apply.

Learn More or Apply Now

Register Now for Day of Science: Philadelphia and Chicago

CURE’s Day of Science event series kicks off in June! Day of Science is a free, educational, networking opportunity for patients, families, medical professionals, researchers, and all those touched by or interested in learning more about epilepsy.

Join us to hear about the latest in epilepsy research and what it means for patients and families, participate in a live Q&A with epilepsy expert panelists, and join small roundtable discussions with the experts. Registration is now open for CURE Day of Science at Children’s Hospital of Philadelphia and Lurie Children’s Hospital of Chicago. Additional locations will be announced in the coming months.

Interested in volunteering? Please contact the Day of Science team at or (312) 255-1801 if you are interested in volunteering in Philadelphia or Chicago.

Learn More

Get Your Limited Edition Hamil-Time T-Shirt

It’s Hamil-Time to find a cure for epilepsy! Get a limited edition Hamil-Time t-shirt, available exclusively on OMAZE’s website. HAMILTON’s Miguel Cervantes and his daughter Adelaide are shown here wearing the Hamil-Time t-shirts. Adelaide was diagnosed with epilepsy at just 7 months old. Proceeds from the Hamil-Time tee will support CURE’s mission of funding epilepsy research initiatives.

Buy Now

Infantile Spasms/Seizure Medication Access Survey for Families and Providers

Have you recently had problems accessing medications for Infantile Spasms or Seizures? The Infantile Spasms Action Network (ISAN), which CURE is a part of, wants to hear from families and providers like you. If your medication access has been limited by availability, payment difficulties, or other issues, tell ISAN about your experience. They will use this information to reduce barriers to medication access.

Take the Survey

Next CURE Events

Get Your Shoes On – FITT and Fashion for a Cure for Epilepsy
Promising Anti-Epileptic Drugs in Development
1:26 The Art of Epilepsy 2018
3rd Annual Ella’s Race for a Cure
Day of Science
All Upcoming Events